Field Safety Notices: 14 to 18 December 2020
List of field safety notices (FSNs) from medical device manufacturers from 14 December to 18 December 2020
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only. If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
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11 November 2020
Moving & handling
MHRA reference: 2020/011/018/291/003
Bausch & Lomb: 23GA Backflush/Extrusion Handpiece blunt
11 December 2020
Phacoemulsification / vitrectomy systems
Model: SUJ11, SUJ14
MHRA reference: 2020/012/014/487/003
Baxter: VERITAS Collagen Matrix 12x25 cm
21 December 2020
Dermal substitues, tissue scaffods
MHRA reference: 2020/012/016/291/007
Dexcom: Dexcom G6 sensor
December 2020
Continuous glucose monitoring systems (CGMS)
MHRA reference: 2020/012/004/701/032
Illumina: VeriSeq NIPT Solution v2
15 December 2020
IVDs, clinical chemistry
MHRA reference: 2020/012/015/487/022
Intersurgical: CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MA
17 December 2020
Nebulizers
MHRA reference:2020/012/016/487/003
Invacare: Action 3 Junior
12 October 2020
Wheelchairs, manual
MHRA reference: 2020/003/011/401/009
Liko AB(Hillrom): Multirall 200
MOD1322
Moving & handling
Model: 3130001
MHRA reference: 2020/012/015/487/014
Mathys: Affinis Inverse glenosphere
08 December 2020
Joint prosthesis, shoulder
Model: 60.30.3036
MHRA reference: 2020/012/011/487/006
Medela Stryker: AXS Universal Aspiration Tubing
07612367052719
Surgical equipment, miscellaneous
Model: 077.0193
MHRA reference: 2020/012/009/601/006
Medisafe(Steris): Distal Duck Kits (M20400) and Duck Bag Humidity Packs (M20350, M20358, M20359)
01 December 2020
Detergents
MHRA reference: 2020/011/020/291/007
Medtronic: ARESTM Antibiotic-Impregnated Catheter
December 2020
Cerebrospinal fluid drainage, external
Model: 91101, 93092, 95001
MHRA reference: 2020/012/011/487/007
Medtronic Delta: Delta Valve, Neonatal, Performance Level 1.0
Delta Valve, Neonatal, Performance Level 2.0 Delta Valve, Neonatal, Performance Level 1.5
December 2020
Implants, non active, hydrocephalus shunts
MHRA reference: 2020/012/016/291/014
Radiometer: AQT90 FLEX analyzers
16 December 2020
IVDs, clinical chemistry
Model: 393-838
MHRA reference: 2020/012/009/487/003
Spacelabs: SENTINEL
08 December 2020
Software as a medical device (SaMD)
Model: 98200 & 98201
MHRA reference: 2020/012/015/487/013
Thermo Fisher Scientific: Remel
10 December 2020
IVDs, Bacteriology
Model: R21524
MHRA reference:2020/012/016/601/011